Feasibility and Effectiveness of Obtaining Consent for Neonatal Screening

摘要

The objective of the investigation was to study informed consent as public policy for mass newborn screening, focusing on phenylketonuria (PKU) screening. Attitudes of providers toward informed consent in general and neonatal genetic screening in particular were assessed through a survey of providers who have administrative or operational responsibility for the implementation of the disclosure form in 38 hospitals in the State with active obstetrical services. The quality of the consent process was also examined, including parental understanding of the disclosed information and parental attitudes toward the meaning and appropriateness of such a requirement. The majority of the providers disapproved of the State regulations requiring informed parental consent prior to screening for PKU but approved mandatory screening for the condition. Despite widespread unawareness of the regulation as reported in an interview, hospitals were generally in compliance with the technical stipulation of the regulations. Regardless of whether they had participated in the disclosure-consent process, mothers were equally divided between those who favored consent before screening and those who did not.